title: Review of 10 years of clinical experience with Chinese domestic trivalent influenza vaccine Anflu®.
abstract: Influenza viruses cause annual winter epidemics globally and influenza vaccination is most effective way to prevent the disease or severe outcomes from the illness, especially in developing countries. However, the majority of the world's total production capacity of influenza vaccine is concentrated in several large multinational manufacturers. A safe and effective preventive vaccine for the developing countries is urgent. Anflu®, a Chinese domestic preservative-free, split-virus trivalent influenza vaccine (TIV), was introduced by Sinovac Biotech Ltd. in 2006. Until now, 20.6 million doses worldwide of Anflu® were sold. Since 2003, 13 company-sponsored clinical studies investigating the immunogenicity and safety of Anflu® have been completed, in which 6642 subjects participated and were vaccinated by Anflu®. Anflu® was generally well tolerated in all age groups, and highly immunogenic in healthy adults and elderly and exceeded the licensure criteria in Europe. This review presents and discusses the experience with Anflu® during the past decade. A new Chinese domestic, preservative-free, unadjuvanted, inactivated split-virus trivalent influenza vaccine (TIV), Anflu®, was introduced into human clinical trials in 2003 and then licensed in China in 2006. The vaccine contains 15 µg/0.5 ml hemagglutinin from each of the 3 influenza virus strains (including an H1N1 influenza A virus subtype, an H3N2 influenza A virus subtype, and an influenza B virus) that are expected to be circulating in the up-coming influenza season. The clinical data pertaining to Anflu® will be reviewed and compared with other TIVs available at present.
authors.affiliation: Sinovac Biotech Co. Ltd.; Beijing, PR China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Sinovac Biotech Co. Ltd.; Beijing, PR China.
authors.forename: Jun-Yu
authors.initials: JY
authors.lastname: Wu
authors.affiliation: Sinovac Biotech Co. Ltd.; Beijing, PR China.
authors.forename: Xu
authors.initials: X
authors.lastname: Wang
authors.affiliation: Sinovac Biotech Co. Ltd.; Beijing, PR China.
authors.forename: Jiang-Ting
authors.initials: JT
authors.lastname: Chen
authors.affiliation: Sinovac Biotech Co. Ltd.; Beijing, PR China.
authors.forename: Ming
authors.initials: M
authors.lastname: Xia
authors.affiliation: Sinovac Biotech Co. Ltd.; Beijing, PR China.
authors.forename: Wei
authors.initials: W
authors.lastname: Hu
authors.affiliation: Sinovac Biotech Co. Ltd.; Beijing, PR China.
authors.forename: Yong
authors.initials: Y
authors.lastname: Zou
authors.affiliation: Sinovac Biotech Co. Ltd.; Beijing, PR China.
authors.forename: Wei-Dong
authors.initials: WD
authors.lastname: Yin
mesh_terms: D002681:China / Q000453:epidemiology; D002986:Clinical Trials as Topic; D005060:Europe; D019267:Hemagglutinin Glycoproteins, Influenza Virus / Q000276:immunology; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology; D053122:Influenza A Virus, H3N2 Subtype / Q000276:immunology; D009981:Influenza B virus / Q000276:immunology; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D007251:Influenza, Human / Q000453:epidemiology* / Q000517:prevention & control*; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D019267:Hemagglutinin Glycoproteins, Influenza Virus; D007252:Influenza Vaccines; D015164:Vaccines, Inactivated
keywords: AnfluⓇ; immunogenicity; safety; split-virus; trivalent influenza vaccine